Measurements to Assess Severity of Epicardial Stenoses (MASES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00760630
Recruitment Status : Suspended (IRB Approval on study expired May 28, 2009)
First Posted : September 26, 2008
Last Update Posted : September 6, 2010
American Heart Association
Information provided by:
University of Cincinnati

Brief Summary:
Newly developed diagnostic parameters have potential to differentiate between epicardial disease and microvascular dysfunction with the help of anatomical details and physiological endpoints and can be used in present clinical settings.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: FFR/CFR and IVUS Early Phase 1

Detailed Description:
The pressure drop coefficient (CDP) is a functional index based on hyperemic dp and u measurements. The lesion flow coefficient (LFC) combines the functional index CDP with an atomic measure (percentage area stenosis) as a single parameter.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Simultaneous Measurements Of Pressure Gradient, Blood Flow and Percentage Area Stenosis Of Coronary Epicardial Lesions To Assess Severity Of Epicardial Stenosis And Myocardial Infarction
Study Start Date : December 2009
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : April 2012

Arm Intervention/treatment
Experimental: CDP LFC
all patients will have this calculation based upon diagnostic parameters with IVUS and FFR and/or CFR
Device: FFR/CFR and IVUS
All patients with clinical indication for cardiac cath will have FFR and IVUS
Other Name: Volcano FFR and IVUS catheters will be used

Primary Outcome Measures :
  1. to detect ischemic heart disease in patients with abnormal stress tests using MPI with SPECT and to determine the presence of significant epicardial stenosis using coronary angiography with simultaneous physiological pressure and flow measurements [ Time Frame: Upon Diagnostic Angiogram and Flow Wire ]

Secondary Outcome Measures :
  1. To compare novel measurements, Pressure Drop Coefficient (CDP) & Lesion Flow Coefficient (LFC), against measured current parameters called Fractional flow reserve (FFR) & Coronary flow reserve (CFR). [ Time Frame: Upon Diagnostic Angiogram and Flow Wire ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Abnormal Myocardial stress perfusion (SPECT) LV EF > 25%

Exclusion Criteria:

  • LV < or + to 25% Serum Creatinine > 2.5 gm/dL Type II HIT Significant co-morbidities Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00760630

United States, Ohio
University Hospital
Cincinnati, Ohio, United States, 45219
Department of Veterans Affairs
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
University of Cincinnati
American Heart Association
Principal Investigator: Mohamed Effat, MD University of Cincinnati
Principal Investigator: Kranthi K Kolli, MS University of Cincinnati
Principal Investigator: Massoud Leesar, MD University of Cincinnati
Principal Investigator: Rupak Banerjee, PhD University of Cincinnati
Principal Investigator: Tarek Helmy, MD University of Cincinnati
Principal Investigator: Srikara Pellukhana, BS University of Cincinnati

Responsible Party: Imran Arif, MD, UNIVERSITY OF CINCINNATI Identifier: NCT00760630     History of Changes
Other Study ID Numbers: UCIRB08031108
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: September 6, 2010
Last Verified: September 2010

Keywords provided by University of Cincinnati:
abnormal stress test
fractional flow reserve
pressure drop coefficient
lesion flow coefficient

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases